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Registration

SOR/2013-134 June 13, 2013

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2013-87-03-01 Amending the Domestic Substances List

Whereas the substances set out in the annexed Order are specified on the Domestic Substances List(see footnote a);

Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of each of those substances under section 74 of the Canadian Environmental Protection Act, 1999(see footnote b);

Whereas the Ministers are satisfied that those substances are not being manufactured in or imported into Canada by any person in a quantity of more than 100 kg in any one calendar year;

And whereas the Ministers suspect that a significant new activity in relation to any of those substances may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999(see footnote c);

Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999(see footnote d), makes the annexed Order 2013-87-03-01 Amending the Domestic Substances List.

Gatineau, June 7, 2013

PETER KENTMinister of the Environment

ORDER 2013-87-03-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. Part 1 of the Domestic Substances List(see footnote 1) is amended by deleting the following:

116-66-5

68583-58-4

101200-53-7

2. Part 2 of the List is amended by adding the following in numerical order:

This table shows the amendments to Part 2 of the List.

Column 1

Substance

Column 2

Significant New Activity for which substance is
subject to subsection 81(3) of the Act

116-66-5 S′

Any activity involving, in any one calendar year, more than 100 kg of the substance 1H-indene, 2,3-dihydro-1,1,3,3,5-pentamethyl-4,6-dinitro-.

For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:

(a) a description of the significant new activity in relation to the substance;

(b) the anticipated annual quantity of the substance to be used;

(c) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the estimated quantity by site;

(d) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);

(e) the information specified in items 2 to 8 of Schedule 5 to those Regulations;

(f) the information specified in items 2 to 11 of Schedule 6 to those Regulations;

(g) a summary of all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;

(h) the identification of every other government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the substance and, if known, the agency’s file number and, if any, the outcome of the assessment and the risk management actions in relation to the substance imposed by the agency;

(i) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity and, if any, the person authorized to act on behalf of that person; and

(j) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity, if they are resident in Canada or, if not, by the person authorized to act on their behalf.

The above information will be assessed within 90 days after the day on which it is received by the Minister.

68583-58-4 S′

Any activity involving, in any one calendar year, more than 100 kg of the substance ethanamine, N-ethyl-N-hydroxy-, reaction products with hexamethylcyclotrisiloxane, silica and 1,1,1-trimethyl-N-(trimethylsilyl)silanamine.

For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:

(a) a description of the significant new activity in relation to the substance;

(b) the anticipated annual quantity of the substance to be used;

(c) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the estimated quantity by site;

(d) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);

(e) the information specified in item 2, paragraphs 3(a) to (e) and items 4 to 8 of Schedule 5 to those Regulations;

(f) the information specified in items 2 to 11 of Schedule 6 to those Regulations;

(g) the analytical information to determine the average particle size and particle size distribution of the substance;

(h) the analytical information to determine the percent surface treatment;

(i) the analytical information to determine the average particle size and, if known, the particle size distribution of the test substance as administered in the human health and ecological toxicity tests required under paragraphs (e) and (f);

(j) a summary of all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;

(k) the identification of every other government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the substance and, if known, the agency’s file number and, if any, the outcome of the assessment and the risk management actions in relation to the substance imposed by the agency;

(l) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity and, if any, the person authorized to act on behalf of that person; and

(m) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity, if they are resident in Canada or, if not, by the person authorized to act on their behalf.

The above information will be assessed within 90 days after the day on which it is received by the Minister.

101200-53-7 S′

Any activity involving, in any one calendar year, more than 100 kg of the substance pyridine, 2-[3-(3-chlorophenyl)propyl]-.

For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:

(a) a description of the significant new activity in relation to the substance;

(b) the anticipated annual quantity of the substance to be used;

(c) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the estimated quantity by site;

(d) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);

(e) the information specified in items 2 to 8 of Schedule 5 to those Regulations;

(f) the information specified in items 2 to 11 of Schedule 6 to those Regulations;

(g) a summary of all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;

(h) the identification of every other government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the substance and, if known, the agency’s file number and, if any, the outcome of the assessment and the risk management actions in relation to the substance imposed by the agency;

(i) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity and, if any, the person authorized to act on behalf of that person; and

(j) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity, if they are resident in Canada or, if not, by the person authorized to act on their behalf.

The above information will be assessed within 90 days after the day on which it is received by the Minister.

COMING INTO FORCE

3. This Order comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Background

On December 8, 2006, the Chemicals Management Plan (CMP) was announced by the Government of Canada to assess and manage substances that may be harmful to human health or the environment. A key element of the CMP is the Challenge initiative, which collected information on the properties and uses of the approximately 200 high priority chemical substances. These 200 chemicals were divided into 12 batches of 10 to 20 chemicals each. The three substances subject to this Order (hereafter “the three substances”) are among the 16 chemicals in batch 12 of the Challenge and are listed below:

Environment Canada and Health Canada conducted screening assessments to determine whether any of the substances in batch 12 are harmful to the environment or human health as defined under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). (see footnote 2) A summary of the final screening assessment reports for 12 of the 16 substances was published in the Canada Gazette, Part I, on January 8, 2011. The final screening assessments for the three substances concluded that they do not meet any of the criteria set out in section 64 of CEPA 1999. However, the three substances are persistent, bio-accumulative, and inherently toxic to non-human organisms and have the potential to cause adverse impacts on the environment.

Use profile

To establish whether the three substances were being manufactured, imported or used in Canada, surveys were published under section 71 of CEPA 1999 in 2006 and 2009. The results from the surveys revealed no reports of manufacture or import of the three substances for commercial purposes in Canada above the reporting threshold of 100 kg in 2005 and 2008.

Significant New Activity (SNAc) provisions of CEPA 1999

Given that the three substances are listed on the Domestic Substances List (DSL), new activities associated with them can be conducted by industry without obligation to notify the Government of Canada. When the Government of Canada is concerned that any significant new activity in relation to a substance may result in harmful effects on human health or the environment, the Minister of the Environment (Minister) may impose notification requirements upon the new activity. (see footnote 3) Given the hazardous properties of the three substances, there is a concern that new activities that have not been assessed may result in risk to the environment or human health. Given this concern, the Minister published a notice of intent in the Canada Gazette, Part I, on January 8, 2011, to inform stakeholders of the Minister’s intent of applying the SNAc provisions of CEPA 1999 to the three substances. (see footnote 4)

Issues and objectives

The final screening assessments concluded that the three substances do not meet any of the criteria under section 64 of CEPA 1999 and are deemed not in commerce currently in Canada. However, given their hazardous properties, new activities that have not been identified or assessed could increase the potential for exposure and may lead to the three substances meeting the criteria set out in section 64 of CEPA 1999. Thus, action is needed to ensure that the Government is notified of any new activities associated with the three substances and the activities undergo ecological and human health risk assessments before they are conducted.

The objective of the Order is to protect the environment and human health by collecting information on significant new activities associated with the three substances before they are undertaken. The collected information will assist the Government in determining whether the new activities will result in risks to the environment or human health.

Description

The Order deletes the three substances from Part 1 of the DSL by removing their CAS Registry Numbers, adds them to Part 2 of the DSL, and indicates, by the addition of the letter S′ following the CAS Registry Numbers, that the three substances are subject to the SNAc provisions of CEPA 1999.

The Order requires any person that intends to import, use or manufacture any of the three substances for any activity involving more than 100 kg of the substance annually to provide a notice to the Minister at least 90 days in advance, including a description of the activity and other prescribed information. The Order outlines the information requirements, including a description of the new activity.

The submitted information will be assessed by Environment Canada and Health Canada within 90 days after it is received to assess the potential environmental and human health risks associated with a new activity and to determine if it requires risk management considerations.

The Order comes into force on the day on which it is registered.

Consultation

On January 8, 2011, a notice of intent to amend the Domestic Substances List was published for a 60-day public comment period in the Canada Gazette, Part I. No comments from stakeholders were received during the 60-day public comment period.

The National Advisory Committee of CEPA 1999 (CEPA NAC) was also given the opportunity to advise the Minister of the Environment and the Minister of Health (ministers) on the notice of intent. No comments were received from CEPA NAC.

“One-for-One” Rule

The “One-for-One” Rule does not apply to the Order as no incremental administrative costs are expected to be incurred by businesses. There are no Canadian companies that are found using the three substances above the reporting threshold. Furthermore, there are no indications that industry’s current activity pattern associated with these substances may change in the future.

Small business lens

The small business lens does not apply to the Order as there are no expected impacts on industry or small business. Canadian companies either are currently using the substances below the threshold or are not captured by the Order. There was no indication that current industrial activity patterns associated with the three substances will change in the future.

Rationale

According to the section 71 surveys, the three substances are neither manufactured in nor imported into Canada for commercial purposes in quantities above the reporting threshold of 100 kg. As a result, the likelihood of exposure in Canada is considered to be low. However, should exposure increase, there may be potential risks to the environment and human health. Given that the three substances are listed on Part 1 of the DSL, activities involving these substances do not require notification and reporting to the Minister. Given the hazardous nature of these substances, future activities that have not been assessed may pose a risk to human health or the environment and may need to be managed, if appropriate. Therefore, maintaining the status quo has been rejected.

Modifying the DSL to apply the SNAc provisions allows the Minister to be informed of new activities involving the three substances. The submitted information will assist the Government of Canada in conducting risk assessments in relation to these activities and determining the potential for the three substances to impact the environment and health of Canadians. Therefore, the Ministers have determined that applying the SNAc provisions to the three substances is the preferred option.

The Order contributes to the protection of the environment and human health by assessing significant new activities of the substance prior to introduction of these activities.

As the three substances are not in commerce, the Order is not expected to have impacts on industry. Should activities associated with the three substances occur above the reporting threshold, costs for generating data and other information to be supplied to the Minister would be incurred. However, it is not possible at this time to accurately estimate the occurrence of any future activities. As a result, providing a total estimate of the cost to industry to meet the notification requirements is not possible at this time.

In the event of notification, the Government of Canada will incur costs for processing the information in relation to the SNAc and for assessing potential health and environmental risks. Furthermore, the Government of Canada will incur costs to ensure compliance with the Order by conducting compliance promotion and enforcement activities. Annual costs associated with these activities are expected to be low, but cannot be accurately estimated given the lack of information regarding potential future activities with the three substances.

In conclusion, although it was not possible to quantitatively estimate the benefits and costs, the overall impact of the Order is expected to be positive.

Implementation, enforcement and service standards

Implementation

The Order comes into force on the day on which it is registered. The compliance promotion activities to be conducted as part of the implementation of the Order will include developing and distributing promotional material, responding to inquiries from stakeholders and undertaking activities to raise industry stakeholders’ awareness of the requirements of the Order.

Enforcement

The Order is made under the authority of CEPA 1999. When verifying compliance with the Order, enforcement officers will apply the Compliance and Enforcement Policy implemented under CEPA 1999. The Compliance and Enforcement Policy sets out the range of possible responses to violations, including warnings, directions,environmental protection compliance orders, ticketing, ministerial orders, injunctions, prosecution, and environmental protection alternative measures (which are an alternative to a court trial after the laying of charges for a CEPA 1999 violation). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for costs recovery.

When an enforcement officer discovers an alleged violation following an inspection or an investigation, the officer will choose the appropriate enforcement action based on the following factors:

Nature of the alleged violation: This includes consideration of the damage, the intent of the alleged violator, whether it is a repeat violation, and whether an attempt has been made to conceal information or otherwise subvert the objectives and requirements of CEPA 1999.

Effectiveness in achieving the desired result with the alleged violator: The desired result is compliance within the shortest possible time and with no further repetition of the violation. Factors to be considered include the violator’s history of compliance with CEPA 1999, willingness to co-operate with enforcement officers, and evidence of corrective action already taken.

Consistency: Enforcement officers will consider how similar situations have been handled in determining the measures to be taken to enforce CEPA 1999.

Service standards

The Department will assess all information submitted as part of SNAc notification and will communicate the result to the notifier 90 days after the information is received.

Footnote 2
Criteria set out under section 64 of CEPA 1999 are to determine whether a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that

(a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;

(b) constitute or may constitute a danger to the environment on which life depends; or

(c) constitute or may constitute a danger in Canada to human life or health.

Footnote 3
As set out in section 80 of CEPA 1999, a significant new activity includes, in respect of a substance, any activity that results in or may result in (1) the entry or release of the substance into the environment in a quantity or concentration that is significantly greater than the quantity or concentration of the substance that previously entered or was released in to the environment, or (2) the entry or release of the substance into the environment or the exposure of potential exposure of the environment to the substance in a manner and circumstances that are significantly different from the manner and circumstances in which the substance previously entered or was released in the environment or potential exposure of the environment to the substance.

Footnote 4
The notice of intent can be found at www.gazette.gc.ca/rp-pr/p1/2011/2011-01-08/pdf/g1-14502.pdf.